Effect of Fluid Deresuscitation With Central Venous Pressure Target 0-4 mmHg in Septic Shock Patients

Overview

A scientific research to prove the safety and effectiveness of TVS 0 – 4 mmHg as a target of resuscitation using furosemide, to improve Perfused Vessel Density (PVD) > 25 mm / mm2, AKI stage (based on KDIGO criteria), CI > 2.5 cc / min / m2 , prevent the incidence of intubation, reduce the duration of ventilator use <120 hours and reduce the length of ICU stay in patients with septic shock after resuscitation

Full Title of Study: “Effectiveness of Fluid Deresuscitation With Central Venous Pressure Target 0-4 mmHg on Capillary Perfusion Density, Acute Kidney Injury Stage, Cardiac Index, and the Intensive Care Unit Length of Stay in Septic Shock Patients After Resuscitation”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Outcomes Assessor)
  • Study Primary Completion Date: June 30, 2020

Detailed Description

The study aims to evaluate the effectiveness of deresuscitation with target CVP 0 – 4 mmHg on septic shock patients in the ICU on capillary perfusion density, AKI stage (based on KDIGO criteria), the incidence of intubation, duration of use of mechanical ventilation, and length of stay in the ICU which can reduce the number of morbidity and mortality.

The study evaluates the difference in capillary perfusion density, AKI stage (based on KDIGO criteria), and the Cardiac index value between groups septic shock patients with CVP 0-4 mmHg on the 7th day after deresuscitation compared with the control group (CVP 8-10 mmHg on the first 7th day after being given deresuscitation).

The study evaluates the difference in the number of intubation incidents, duration of use ventilators, and care in the ICU between groups of patients with septic shock CVP 0 – 4 on day 28 after being given a degree of comparison with a control group (CVP 8-10 mmHg on day 28th after being deresuscitation).

Interventions

  • Procedure: Fluid resuscitation and furosemide administration (bolus and continuous) with central venous pressure target 8 – 10 mmHg
    • Crystalloid loading or furosemide administration with the CVP target 8-10 mmHg is reached in septic shock patients
  • Procedure: Fluid deresuscitation and furosemide administration (bolus and continuous) with central venous pressure target 0 – 4 mmHg
    • active fluid removal with furosemide bolus and continuous or crystalloid loading until the CVP target 0-4 mmHg is reached in septic shock patients

Arms, Groups and Cohorts

  • Active Comparator: Central Venous Pressure 8 – 10 mmHg
    • Furosemide deresuscitation or crystalloid loading until the CVP target 8-12 mmHg is reached
  • Experimental: Central Venous Pressure 0 – 4 mmHg
    • Furosemide deresuscitation or crystalloid loading until the CVP target 0-4 mmHg is reached

Clinical Trial Outcome Measures

Primary Measures

  • Capillary Perfusion Density
    • Time Frame: 7 days
    • Capillary Perfusion Density measurement using MicroScan every 24 hours during deresuscitation

Secondary Measures

  • Acute Kidney Injury Stage
    • Time Frame: 7 days
    • AKI staging using KDIGO criteria every 24 hours during deresuscitation
  • Cardiac Index
    • Time Frame: 7 days
    • cardiac index measurement using bio-impedance cardiometry every 24 hours during deresuscitation
  • Neutrophil Gelatinase-Associated lipocalin (NGAL)
    • Time Frame: 1st and 7th day
    • NGAL measurement from urinary sample using NGAL ELISA method at 1st and 7th day during deresuscitation
  • Renal Resistive Index (RRI)
    • Time Frame: 1st and 7th day
    • RRI measurement using renal doppler ultrasonography at 1st and 7th day during deresuscitation
  • Length of ICU stay
    • Time Frame: 28 days
    • length of ICU stay in days during and after deresuscitation

Participating in This Clinical Trial

Inclusion Criteria

  • Septic shock patients who meet the diagnosis criteria for quick SOFA and KDIGO 1 stage AKI (creatinine value 1.5 times OR creatinine value> 0.3 initial OR urine production <0.5 ml/kg/hour for 6-12 hours
  • Patients, both men and women, in the age range of 18 – 60 years
  • Patients who experience post clean operative sepsis
  • Patients who agree to attend the study by signing informed consent

Exclusion Criteria

  • Patients with primary heart problems, right or heart failure suffer from congenital heart disease
  • Have severe chronic obstructive pulmonary disease, patients with severe pleural effusion
  • Patients who, based on ultrasound examination, found stones or tumors in the kidney during the study period
  • CKD patients are based on history taking and physical examination
  • DNR (do not resuscitate) patients

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Indonesia University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Dita Aditianingsih, MD, PhD, Anesthesiologist Consultant – Indonesia University
  • Overall Contact(s)
    • Dita Aditianingsih, M.D, Ph.D, +628151819244, ditaaditiaa@gmail.com

Citations Reporting on Results

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Dellinger RP, Levy MM, Carlet JM, Bion J, Parker MM, Jaeschke R, Reinhart K, Angus DC, Brun-Buisson C, Beale R, Calandra T, Dhainaut JF, Gerlach H, Harvey M, Marini JJ, Marshall J, Ranieri M, Ramsay G, Sevransky J, Thompson BT, Townsend S, Vender JS, Zimmerman JL, Vincent JL; International Surviving Sepsis Campaign Guidelines Committee; American Association of Critical-Care Nurses; American College of Chest Physicians; American College of Emergency Physicians; Canadian Critical Care Society; European Society of Clinical Microbiology and Infectious Diseases; European Society of Intensive Care Medicine; European Respiratory Society; International Sepsis Forum; Japanese Association for Acute Medicine; Japanese Society of Intensive Care Medicine; Society of Critical Care Medicine; Society of Hospital Medicine; Surgical Infection Society; World Federation of Societies of Intensive and Critical Care Medicine. Surviving Sepsis Campaign: international guidelines for management of severe sepsis and septic shock: 2008. Crit Care Med. 2008 Jan;36(1):296-327. Erratum in: Crit Care Med. 2008 Apr;36(4):1394-6.

Dellinger RP, Levy MM, Rhodes A, Annane D, Gerlach H, Opal SM, Sevransky JE, Sprung CL, Douglas IS, Jaeschke R, Osborn TM, Nunnally ME, Townsend SR, Reinhart K, Kleinpell RM, Angus DC, Deutschman CS, Machado FR, Rubenfeld GD, Webb SA, Beale RJ, Vincent JL, Moreno R; Surviving Sepsis Campaign Guidelines Committee including the Pediatric Subgroup. Surviving sepsis campaign: international guidelines for management of severe sepsis and septic shock: 2012. Crit Care Med. 2013 Feb;41(2):580-637. doi: 10.1097/CCM.0b013e31827e83af.

Rhodes A, Evans LE, Alhazzani W, Levy MM, Antonelli M, Ferrer R, Kumar A, Sevransky JE, Sprung CL, Nunnally ME, Rochwerg B, Rubenfeld GD, Angus DC, Annane D, Beale RJ, Bellinghan GJ, Bernard GR, Chiche JD, Coopersmith C, De Backer DP, French CJ, Fujishima S, Gerlach H, Hidalgo JL, Hollenberg SM, Jones AE, Karnad DR, Kleinpell RM, Koh Y, Lisboa TC, Machado FR, Marini JJ, Marshall JC, Mazuski JE, McIntyre LA, McLean AS, Mehta S, Moreno RP, Myburgh J, Navalesi P, Nishida O, Osborn TM, Perner A, Plunkett CM, Ranieri M, Schorr CA, Seckel MA, Seymour CW, Shieh L, Shukri KA, Simpson SQ, Singer M, Thompson BT, Townsend SR, Van der Poll T, Vincent JL, Wiersinga WJ, Zimmerman JL, Dellinger RP. Surviving Sepsis Campaign: International Guidelines for Management of Sepsis and Septic Shock: 2016. Intensive Care Med. 2017 Mar;43(3):304-377. doi: 10.1007/s00134-017-4683-6. Epub 2017 Jan 18.

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Payen D, de Pont AC, Sakr Y, Spies C, Reinhart K, Vincent JL; Sepsis Occurrence in Acutely Ill Patients (SOAP) Investigators. A positive fluid balance is associated with a worse outcome in patients with acute renal failure. Crit Care. 2008;12(3):R74. doi: 10.1186/cc6916. Epub 2008 Jun 4.

Van Biesen W, Yegenaga I, Vanholder R, Verbeke F, Hoste E, Colardyn F, Lameire N. Relationship between fluid status and its management on acute renal failure (ARF) in intensive care unit (ICU) patients with sepsis: a prospective analysis. J Nephrol. 2005 Jan-Feb;18(1):54-60.

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Cordemans C, De Laet I, Van Regenmortel N, Schoonheydt K, Dits H, Huber W, Malbrain ML. Fluid management in critically ill patients: the role of extravascular lung water, abdominal hypertension, capillary leak, and fluid balance. Ann Intensive Care. 2012 Jul 5;2(Suppl 1 Diagnosis and management of intra-abdominal hyperten):S1. doi: 10.1186/2110-5820-2-S1-S1. eCollection 2012.

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